Impact of Body Composition on the Prognosis and Toxicity of Patients Diagnosed With Recurrence or Metastasic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treated With Immune Checkpoint Inhibitors (ICI)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
研究概览
简要总结
The purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
详细描述
Body composition including sarcopenia (loss of muscle mass), sarcopenic obesity, and mioesteaosis has been well reported to be an independent predictors of mortality, toxicity, and complications in cancer patients with different locations and treatments. However, there are currently no data on impact of body composition and the oncological outcomes in SCCHN patients treated with immune checkpoint inhibitors (ICI) due to recurrence or metastasic disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with recurrence or metastatic SCCHN treated with antiPDL1, antiPD1 or antiCTLA-4 drugs, alone or in combination within our institution.
- •Patients who have previously signed informed consent.
- •Patients with measurable tumor lesions.
排除标准
- •Patients with non-measurable lesions.
- •Patients who do not sign the informed consent.
- •Patients not treated with immunotherapy.
- •Patients in a double-blind trial in whom the assigned branch is not known.
结局指标
主要结局
Evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
时间窗: at baseline
Assessed by CT scan at L3 level
次要结局
- Evaluate the impact of adipose tissue as a predictor of survival and toxicity(6 months)
- - To evaluate the impact of malnutrition and weight loss on overall survival, recurrence-free survival, locoregional control, and toxicity in patients with recurrence or metastatic SCCHN treated with immunotherapy-based regimens.(2-3 months and 6 months)
- Evaluate baseline muscle mass as a predictive biomarker of toxicity(2-3 months and 6 months)
- Evaluate changes in body composition(2-3 months and 6 months)
- Evaluate the need for nutritional support throughout the treatment and the type if so(through study completion, on average of 6 months)
- Observe the correlation of a lower muscle mass with an increase in inflammatory parameters and oncological outcomes(2-3 months and 6 months)